Application 022029

Type: NDA
Sponsor: HISAMITSU PHARM CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SALONPAS	MENTHOL; METHYL SALICYLATE	PATCH;TOPICAL	3%;10%	Yes	Yes
002	SALONPAS	MENTHOL; METHYL SALICYLATE	PATCH;TOPICAL	3%;10%	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022029-001	SALONPAS	MENTHOL; METHYL SALICYLATE	3%;10%	PATCH / TOPICAL		RLD, RS	2008-02-20
N022029-002	SALONPAS	MENTHOL; METHYL SALICYLATE	3%;10%	PATCH / TOPICAL		RLD, RS	2012-11-05

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022029-001	9233184	2027-08-01	Drug product	2016-02-11
N022029-001	8809615	2030-01-03	Drug product	2014-08-19
N022029-002	9233184	2027-08-01	Drug product	2016-02-11
N022029-002	8809615	2030-01-03	Drug product	2014-08-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`2680178bc6a6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NUMBING	MENTHOL	FlexiGo Inc	4ce416dd-2430-4648-e063-6294a90ab199	2026-03-13	Warnings	Exact identifier application applno (NDA): 022029 application number: NDA022029
Salonpas Pain Relief	MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	acd7ba91-221a-485a-ad1f-dd41ed155656	2025-03-14	Warnings	Exact identifier application applno (NDA): 022029 application number: NDA022029 ndc (product): 46581-675
Salonpas Pain Relief	MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2	2025-03-14	Warnings	Exact identifier application applno (NDA): 022029 application number: NDA022029 ndc (product): 46581-670
Salonpas Arthritis Pain	MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	2e88c933-89e6-4a48-be7a-dc6a36e5c8f8	2025-03-14	Warnings	Exact identifier application applno (NDA): 022029 application number: NDA022029 ndc (product): 46581-680
Salonpas Arthritis Pain	MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	a6518167-fe32-43b2-b736-ba01ac69c12d	2024-12-13	Warnings	Exact identifier application applno (NDA): 022029 application number: NDA022029 ndc (product): 46581-685

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46581-670	Salonpas Pain Relief	Menthol, Methyl Salicylate	Hisamitsu Pharmaceutical Co., Inc.	NDA	Current
46581-670	Salonpas Pain Relief	Menthol, Methyl Salicylate	Hisamitsu Pharmaceutical Co., Inc.	NDA	Current
46581-670	Salonpas Pain Relief	Menthol, Methyl Salicylate	Hisamitsu Pharmaceutical Co., Inc.	NDA	Current
46581-675	Salonpas Pain Relief	Menthol, Methyl Salicylate	Hisamitsu Pharmaceutical Co., Inc.	NDA	Current
46581-675	Salonpas Pain Relief	Menthol, Methyl Salicylate	Hisamitsu Pharmaceutical Co., Inc.	NDA	Current
46581-675	Salonpas Pain Relief	Menthol, Methyl Salicylate	Hisamitsu Pharmaceutical Co., Inc.	NDA	Current
46581-675	Salonpas Pain Relief	Menthol, Methyl Salicylate	Hisamitsu Pharmaceutical Co., Inc.	NDA	Current
46581-675	Salonpas Pain Relief	Menthol, Methyl Salicylate	Hisamitsu Pharmaceutical Co., Inc.	NDA	Current
46581-680	Salonpas Arthritis Pain	Menthol, Methyl Salicylate	Hisamitsu Pharmaceutical Co., Inc.	NDA	Current
46581-680	Salonpas Arthritis Pain	Menthol, Methyl Salicylate	Hisamitsu Pharmaceutical Co., Inc.	NDA	Current
46581-680	Salonpas Arthritis Pain	Menthol, Methyl Salicylate	Hisamitsu Pharmaceutical Co., Inc.	NDA	Current
46581-685	Salonpas Arthritis Pain	Menthol, Methyl Salicylate	Hisamitsu Pharmaceutical Co., Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83689	SUPPL	2025-10-07
83683	SUPPL	2025-10-07
69281	SUPPL	2021-11-09
69265	SUPPL	2021-11-05
57523	SUPPL	2019-02-13
57454	SUPPL	2019-02-06
16797	SUPPL	2014-02-14
6723	SUPPL	2014-02-04
38107	SUPPL	2014-01-15
6722	SUPPL	2013-04-01
29105	SUPPL	2012-11-07
6721	SUPPL	2011-06-07
6720	SUPPL	2010-09-15
44667	ORIG	2010-05-03
42394	ORIG	2010-05-03
16796	SUPPL	2009-06-29
6719	SUPPL	2009-06-24
29104	SUPPL	2008-08-25
29103	ORIG	2008-02-26
51355	SUPPL	1900-01-01
51354	SUPPL	1900-01-01
51353	SUPPL	1900-01-01
51352	SUPPL	1900-01-01